NCT00801164

Exploratory Study of Iocide Oral Rinse in a Diabetic Population

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Biomedical Development Corporation · Industry
• Sex: All
• Age: 35 Years
• Healthy volunteers: Accepted

Summary

The goals of this exploratory study are to 1)examine an investigational oral rinse as an adjunctive agent to scaling and root planing in treating chronic periodontitis in a periodontitis-susceptible diabetes population, and 2) evaluate its effect on glycemic control and biomarkers of systemic inflammation.

Detailed description

This double-blind prospective pilot study will evaluate the effects of an investigational oral rinse as an adjunctive agent to non-surgical periodontal intervention for patients with type 2 diabetes mellitus. Approximately thirty (30) adult (35 years or older) patients with type 2 diabetes mellitus with untreated chronic periodontitis of moderate or worse severity will be enrolled in the 6-month study to provide 24 evaluable subjects (12 per group). All subjects enrolled in the trial will receive standard periodontal therapy including scaling and root planing (SRP). Half will be randomized to receive the investigational oral rinse adjunctively twice daily; the other half will receive placebo rinse twice daily. Study participants will be treated with either Iocide or placebo rinse for the first 90 days of the study only. Follow up examinations will be performed at six months. Evaluation of biological markers associated with systemic inflammation and diabetes will be performed at baseline, three months, and six months. The primary study outcome is clinical measurement of chronic periodontitis (gingival index, bleeding on probing, probing depth, clinical attachment level). Secondary outcomes are change in HbA1c and markers of systemic inflammation measured by serum C-reactive protein, plasma TNF-a, and IL-6.

Conditions

• Diabetes Type 2
• Periodontitis

Interventions

Type	Name	Description
DRUG	Frio Mouth Rinse Placebo	Prescription Mouth Rinse. Rinse with 15ml twice daily then expectorate.
DRUG	Frio Mouth Rinse	Prescription Mouth Rinse. Rinse with 15ml twice daily then expectorate.

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-04-01
• Completion: 2010-06-01
• First posted: 2008-12-03
• Last updated: 2012-02-02

Locations

1 site across 1 country: United States